The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

5926–5950 of 21595

  • ModerateFDA (Devices)·Z-1484-2021·2021-04-28

    Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0449-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Red Dye

    USA Lanka Inc. is recalling Motha Jelly Crystals Strawberry Flavoured Jelly because it contains undeclared FD&C Red #40.

    Product
    Motha Jelly Crystals Strawberry Flavoured Jelly , Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1485-2021·2021-04-28

    Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0448-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Artificial Dyes

    USA LANKA INC is recalling Motha Jelly Crystals because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Motha Jelly Crystals - Mango Flavoured Jelly, Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0445-2021·2021-04-28

    Thai Home Satay Peanut Sauce Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Satay Peanut Sauce due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Satay Peanut Sauce packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004078 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1440-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2021·2021-04-28

    Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·015-2021·2021-04-24

    More Than Gourmet Recalls Beef and Veal Broth Due to Hydraulic Oil Contamination

    More Than Gourmet is recalling beef and veal broth products that may contain hydraulic oil. No illnesses have been reported.

    Product
    Ajinomoto Health & Nutrition North America — More Than Gourmet, Inc. Recalls Beef And Veal Broth And Stock Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2021·2021-04-21

    Spartan Chemical Recalls foamyiQ Hand Sanitizer Due to Manufacturing Deviations

    Spartan Chemical Company is voluntarily recalling 26,328 cartridges of foamyiQ Lemon Blossom Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2021·2021-04-21

    Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents for Sealed Tube Defect

    Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System because rehydration buffer tubes were not adequately sealed, potentially causing unresolved test results.

    Product
    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1430-2021·2021-04-21

    Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors

    Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.

    Product
    MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0429-2021·2021-04-21

    J-Basket Seaweed Snack Recalled for Undeclared Food Dyes

    JFC International is recalling J-Basket Premium Korean Seaweed Snack because Wasabi flavor packages were incorrectly labeled as Original, failing to declare FD&C Yellow 5 and FD&C Blue No 1.

    Product
    J-Basket Premium Korean Seaweed Snack - Wasabi flavor on outer wrap for 3 inner packages Inner packages labeled J-Basket Premium Seaweed Snack - Original. Net Wt 0.52 oz. (15g) 3-0.17 oz. (5g) packs Distributed by JFC International Inc., Los Angeles, CA 90040 Wasabi outer packa
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1409-2021·2021-04-21

    OriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling

    OriGen Biomedical is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates.

    Product
    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1423-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1429-2021·2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2021·2021-04-21

    Biomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues

    Biomerieux is recalling VIDAS CMV IgM test kits due to reported calibration issues. The recall affects 18,705 kits distributed nationwide and internationally.

    Product
    VIDAS¿ CMV IgM 30 Tests
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2021·2021-04-21

    Centinel Spine Recalls Prodisc C Devices Missing Orientation Marking

    Centinel Spine is recalling 49 Prodisc C cervical disc prostheses because the 'UP' orientation marking is missing from the superior plate.

    Product
    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled Due to Growth Issues

    Remel Inc is recalling 408 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy E2 Sanitizing Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 2,152 containers of Lite'n Foamy E2 Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    LITE NFOAMY E2 SANITIZING HANDWASH — LITE NFOAMY E2 SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0622-2021·2021-04-21

    Novo Nordisk Recalls Victoza Injection Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of Victoza (liraglutide) injection because they were stored below 32°F, potentially causing loss of efficacy and device damage.

    Product
    VICTOZA — VICTOZA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2021·2021-04-21

    Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

    Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
    Category
    Drug
    Distribution
    Distributed nationwide